Endovascular Exclusion of Thoracic Aortic Aneurysms

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
Eagleton, Matthew, M.D.
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00583817
First received: December 20, 2007
Last updated: February 6, 2014
Last verified: February 2014

December 20, 2007
February 6, 2014
May 2001
December 2020   (final data collection date for primary outcome measure)
Safety [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]
Saftey [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00583817 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endovascular Exclusion of Thoracic Aortic Aneurysms
Endovascular Exclusion of Thoracic Aortic Aneurysms

The purpose of this study is to assess the role of ascending, arch or descending thoracic aortic aneurysm exclusion using a novel endovascular prosthesis in high risk surgical patients.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thoracic Aortic Aneurysms
  • Thoracic Aortic Dissections
  • Thoracoabdominal Aneurysms
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
  • 1
    Primary Arm
    Intervention: Device: Endovascular stent-graft implantation
  • 2
    Symptomatic/Rupture Arm
    Intervention: Device: Endovascular stent-graft implantation
  • 3
    Ascending Aortic Arm
    Intervention: Device: Endovascular stent-graft implantation
  • 4
    Arch Branch Arm
    Intervention: Device: Endovascular stent-graft implantation
Brown CR, Greenberg RK, Wong S, Eagleton M, Mastracci T, Hernandez AV, Rigelsky CM, Moran R. Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives. J Vasc Surg. 2013 Sep;58(3):573-81. doi: 10.1016/j.jvs.2013.02.239. Epub 2013 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
459
December 2020
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. High risk for conventional surgical treatment of their aortic disease
  2. Life expectancy greater than 2 years
  3. Suitable arterial anatomy
  4. Absence of systemic disease or allergy that precludes an endovascular repair
  5. Capable of giving informed consent and willingness to comply with follow up schedule

Exclusion Criteria:

  1. Pregnancy
  2. History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
  3. Allergy to stainless steel or polyester
  4. Unwilling to comply with follow up schedule
  5. Serious or systemic groin infection
  6. An uncorrectable coagulopathy
Both
18 Years and older
No
Contact: Yuki Kuramochi, RN, BSN 216-445-4063 kuramoy@ccf.org
United States
 
NCT00583817
G000101, IRB 3917
Yes
The Cleveland Clinic
The Cleveland Clinic
Eagleton, Matthew, M.D.
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
The Cleveland Clinic
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP